Validation Specialist
This role is accountable for supporting all validation activities associated with the successful qualification of new tools and product introductions.
* Develop and execute process validation protocols and reports for new product introductions and revalidations due to process/material improvements utilizing scientific/technical knowledge.
* Create and implement solutions to sustain and improve our Quality Management System (QMS).
* Maintain and support compliance with ISO 13485 and ISO 14001 systems standards.
* Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
Key Responsibilities:
1. Generate risk assessments covering cleaning, validation, and process.
2. Review and execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) protocols.
3. Directly support regulatory audits and quality inspections.
4. Prepare and deliver training modules as required.
5. Analyze data and make informed decisions/recommendations based on conclusions reached.
6. Support continuous improvement through Lean Six Sigma methodologies.
7. Execute/develop change controls.
8. Perform root cause analysis of system failures and substandard performance, using standard tools and methods (e.g., FMEA, Fishbone diagrams, 5-why method).
9. Implement corrective actions through our Change Management System.
10. Collaborate or lead cross-functional teams, including liaising with vendors on projects.